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QA Manager GCP - Basel

Employer
Umbilical Life
Location
Canton of Basel-Stadt (CH)
Salary
Negotiable
Start date
17 Sep 2019
Closing date
17 Oct 2019

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Discipline
Quality, Auditor, GCP
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

My client are an extremely exciting company that has a start-up feel but with Large Pharma levels of investment and infrastructure. This a 12 month very well paid contract based on site in Basel.

This role will involve managing the QA for a range of clinical trials going on around Europe and on-site. You will be assisting the Clinical Project Manager to ensure quality remains at the highest throughout the different phases. There will also be a portion of your role which involves site visits and audits.

Please get in touch as soon as possible as this is an urgent contract role. I have put some information below about the responsibilities of this role.

Job Description

  • Work as per the defined strategy for the global clinical audit program (e.g. site, vendor, process)
  • Plan, perform, and report audits (e.g. site, vendor, process) using considerable latitude in determining best practice and approach
  • Develop own area of ICH-GCP expertise with limited supervision (e.g. self-training, knowledge acquisition by reading/assisting to course identify by himself) 
  • Lead the preparation, facilitation and follow up of inspections by national and international regulatory authorities
  • Facilitate the CAPAs elaboration and follow-up
  • Escalate serious / continuing non-compliance issues as appropriate
  • Make a significant contribution to ensure that QS documents creation and management is done in accordance with ICH-GCP requirements / regulations
  • Contribute to process improvements and trouble shooting
  • Maintain awareness / expertise in international ICH-GCP requirements
  • Provide leadership and direction on ICH-GCP related activities / issues
  • Work closely with CRO Clinical Trial Teams
  • Support CRO staff in order to make a significant contribution to the implementation and maintenance of a robust and compliant clinical

Quality Management System and clinical trial framework by different ways (e.g. provide training to CD staff, feedback to ICH-GCP questions)

 

  • Highly contribute to develop/improve CQA tools and processes
  • Represent CQA in internal and external meetings and particularly represent Team Leader CQA when he/she is not available
  • Perform any other CQA task that could help to achieve a high adherence to ICH-GCP requirements

Candidate Requirements

  • Bachelor degree or equivalent education/degree in (life) sciences or healthcare
  • Experienced in Clinical Research & Development. At least 6 years of experience in pharmaceutical industry/health authority with at least 3 years of experience

in Quality Assurance / Auditing (QA) within the ICH-GCP environment.

 

  • In-depth knowledge of global ICH-GCP requirements and pharmaceutical industry practices
  • Ability to work as a team player and independently
  • Reliable, conscientious, agile/flexible
  • Proven record of excellent problem solving, risk analysis and negotiation skills
  • Interest and knowledge of requirements for electronic tools used in clinical trials (e.g. eTMF, ePRO, eSource)
  • Experience in medical device and/or combination product will be an added value
  • Strong writing, communication and listening skills
  • Experience in international cross-cultural relations
  • Very good English knowledge (written and spoken)

Company

Umbilical will be a world leading provider of workforce solutions in Science, Technology and Engineering. 

Blending innovation and a commitment to entrepreneurship, we will ensure our customers and colleagues achieve the highest levels of satisfaction.

With nearly 75 years of workforce industry experience between us we know a lot, but not everything. 

We have created a Mission, Vision and a set of clear Values, providing‘guiding light’ as we all start building this Culture, or as we call it the CODE.   

 

Company info
Website
Telephone
011 6 461 0070
Location
Premier House
9 Rutland Street
Leicester
LE1 1RE
United Kingdom

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